GLEPID Tablets 3 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
GLIMEPIRIDE
Available from:
Rowex Ltd
Dosage:
3 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2006-02-03
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0711/080/003
Case No: 2029953
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GLEPID 3 MG TABLETS
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 12/03/2007 until 01/02/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/03/2007_
_CRN 2029953_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glepid 3 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg glimepiride
For excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
A light yellow, flat, oblong, scored tablet encoded G breakline 3 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glimepiride is indicated for type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not
adequate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
For the different dosage regimens appropriate strengths are available.
The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of
blood
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